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Automated and Rapid Microbiological Tests - A Worldwide Market Review

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High prevalence of infectious diseases and sexually transmitted diseases (STDs) continue to drive the automated and rapid tests market, as need for quicker, higher volume and more accurate methods of testing gains importance. With humans and bacteria locked in a perennial biological warfare, there exists a perpetual need for new and advanced rapid microbial testing methods and instruments. Hitherto growth in the automated microbiological test systems market stemmed from laboratories worldwide embarking on the transition from manual to automated forms of testing.

Technology developments and changes have initiated sweeping changes in the market for automated and rapid microbiological tests. With probe tests threatening the survival of immunoassay based rapid tests and with advances in automated microbiological testing systems promising potential opportunities, the landscape is fraught with a unique mixture of opportunities and related threats. The new methods offer greater speed, accuracy, specificity and sensitivity than can be achieved with conventional culturing or immunoassay methods. Molecular diagnostics is the new enabling technology of numerous next generation rapid microbiology test kits.

These and other market data and trends are presented in "Automated and Rapid Microbiological Tests: A Worldwide Market Review" by BizAcumen, Inc. Our reports are designed to be most comprehensive in geographic coverage and vertical market analyses.

AUTOMATED AND RAPID MICROBIOLOGICAL TESTS BMR-1008

CONTENTS

1. METHODOLOGY 1

Study Reliability and Reporting Limitations 1

Disclaimers 2

Quantitative Techniques & Reporting Level 3

2. GLOBAL MARKET OVERVIEW AND OUTLOOK 4

Outlook 4

Evolutionary Battle Against Bugs Drives Future of the Market 4

Automated Microbiological Tests: A Pesky Gray Area in the

Clinical Diagnostics Market 4

Traditional Rapid Microbiological Tests Destined to Go Out

With the Old 5

A Current & Future Analysis 6

Macro: The Big Picture 6

Deciding the Market's Future 6

A Holistic Peek into a Few Noteworthy Trends 7

Biotechnology & Rapid Microbial Tests 8

Automated & Rapid Microbiological Tests: "Current Market Stance" 8

A Business Case for Automated & Rapid Microbiological Testing 9

Near Patient Testing: An Offshoot of Rapid Microbiological Tests 10

Pros & Cons of Near Patient Testing 10

Role of Near Patient Testing in Reducing Antibiotic

Resistance in Humans 11

The Pre/Post Microbial Rapid Testing Era: A Review 11

Market Structure 12

Competitive Setup of the Diverse Automated & Rapid

Microbiology Products Market 12

Historic Data 13

3. TRENDS & ISSUES 13

Advancements in Molecular Diagnostics - A Boon or a Threat 13

Antibiotic Resistant Bacteria Throws the Spotlight On

Microbial Testing 14

Instant Detection of Pathogens - A New Epoch in the Fight for

Survival 15

Lower Cost Rapid Tests Built on Multiple Sampling Modalities -

Gaining Momentum 15

"Time Constraints?" - Rapid Tests to the Rescue 15

Rapid HIV Tests: A New Age Diagnostic Weapon Against the

Killer Disease 16

Accuracy/Reliability of Home HIV Testing: A Bone of Contention 17

Development of Near Patient Test Kits: A Market Driven Phenomenon 17

Near Patient Test Kits: A Rumination of Possibilities 18

Automated Blood Culture Systems: A Winning Edge in the Fight

Against Bacteremia 18

Leading Food Processors Resort to Rapid Microbiological Testing 19

Impact of Food Scares on Rapid Microbiological Tests Market 20

Demand for Microbiological Tests & Level of QC in the Food

Industry 21

Rapid Tests Creating Brighter Avenues in Food Microbiology

Testing Market 22

Dire Need to Nip Operating Costs Throws the Spotlight on Rapid

Tests 22

Key Advantages/Benefits of Rapid Microbiological Tests on Food 23

Food Packages of the Future Ingrained with Microbial Alert

Systems 23

Technology Innovations in Rapid Food Microbial Testing 24

Obtaining Regulatory Approval - A Major Non-Technical Hindrance 24

4. FACTORS INFLUENCING THE MARKET 25

Continuing Biological Warfare with Pathogens Sparks Market Growth 25

Innovative Products - A Key Growth Strategy 25

Other Market Drivers in a Capsule 25

Low Turnaround Times Skyrocket Demand 25

Greater Patient Awareness 26

Rising Incidence of STDs Kindles Universal Market Acceptance 26

Ultra-Rapid HIV-Screening Tests- A Strong Fight against HIV-

Epidemic 26

Validation of Rapid Microbiological Tests: An Imperative

Prerequisite 27

Non-Conformance to Testing Requirements: A Weighty Concern 28

Influenza - Boosting Rapid Test Prospects 28

5. PRODUCT FACTS 29

1. Clinical Applications 29

Automated Identification and Susceptibility Systems 29

Automated Blood Culture Systems 30

Automated Tuberculosis Systems 30

Streptococcal Infection Rapid Tests 30

GC/Chlamydia Rapid Tests 30

Other Automated & Rapid Microbiological Tests 30

2. Non-Clinical Applications 31

6. CORPORATE DEVELOPMENTS 31

BD Establishes New Rapid Diagnostic Products Manufacturing

Facility in China 31

Quidel Corporation Obtains CLIA Waiver from FDA for its

QuickVue(R) RSV Test 31

Siemens Obtains US FDA Approval for its VERSANT(TM) 440 Molecular

System (USA) 31

bioMérieux to Market Wescor's Customized Slide Stainer

Instruments under bioMérieux Brand 32

Schering-Plough and OraSure Ink Collaboration Agreement for

Developing Rapid Oral HCV Test 32

Abbott Obtains US FDA Approval for its Automated HTLV-I/HTLV-

II Blood Screening Test (USA) 33

Quidel and bioMérieux Form a Long-term Alliance in Rapid

Diagnostic Tests 33

BD Diagnostics Obtains US FDA Approval for BD GeneOhm(TM) StaphSR

Assay 33

Meridian Bioscience Rolls Out Two New Rapid Tests for

Detecting Epstein- Barr Virus 33

Oxoid Introduces Staph Plus System for Identifying

Staphylococcal Species 34

Meridian Bioscience Obtains US FDA Approval for Two New Rapid

Tests 34

Siemens AG Acquires Dade Behring 34

Thermo Fisher Scientific Teams Up with KBA for Expanding its

Microbiology Business Division in Lenexa 35

OraSure and SCMS Enter into an Agreement for Supplying

OraQuick(R) HIV Test to PEPFAR Countries 35

Abbott Obtains US FDA Approval for its Fully Automated PRISM®

HCV Test 35

Gen-Probe Obtains US FDA Approval for its PROCLEIX® TIGRIS®

System for Testing Donated Blood 35

AdvanDx Ropes in bioMérieux for Distributing its Rapid

Diagnostic Tests in US 36

3M and Gen-Probe Join Hands to Develop Rapid Molecular Tests

For Detecting HAIs (USA) 36

Gen-Probe's PROCLEIX® TIGRIS® System Obtains US FDA Approval

for Screening Donated Blood for West Nile Virus 37

3M Acquires Acolyte Biomedica 37

Formation of Siemens Medical Solutions Diagnostics 38

bioMérieux Bags Contract to Provide VITEK® 2 System for

Scottish NHS Labs 38

bioMérieux Licenses NorChip's HPV Test Technology for Cervical

Cancer 38

bioMérieux in Strategic Agreement with Cepheid for Sepsis Assays 39

3M Health Care Creates New Medical Diagnostics Unit 39

Schering-Plough & OraSure to Develop Rapid Oral HCV Test 40

Siemens Healthcare Diagnostics Launches MicroScan® WalkAway®

plus Diagnostic Microbiology Systems 40

Bio-Rad Launches a Rapid test for Screening MRSA, MRSASelect(TM)

test, in US 40

bioMérieux Introduces VIDAS®, an automated Clostridium

difficile A & B Toxins Detection Test 41

Oxoid Launches Remel Wellcolex® Colour Tests for Testing

Shigella, E. coli O157 and Salmonella 41

Siemens Healthcare Diagnostics Obtains Health Canada Approval

for its VERSANT 440 Molecular System 41

Oxoid Unveils Remel Xpect(TM) Clostridium Difficile Toxin A/B Test 42

Neogen Introduces Soleris System 42

ATCC Introduces Authenticult(TM) Quality Control Microbiological

Testing Tool 42

Bio-Rad Introduces New EBV Kits 43

Roche Seeks FDA Marketing Approval for Hepatitis C Virus Test 43

Roche Seeks US FDA Approval for its Cobas TaqScreen MPX Test 43

FDA Clears Usage of TIGRIS® System for Testing WNV in Donated

Blood 43

FDA Approves ImmunoCard STAT!® EHEC for Detecting E. coli

Infection 44

7. MAJOR PLAYERS 44

Abbott Laboratories (USA) 44

Abbott Diagnostics (USA) 44

Becton Dickinson and Company (USA) 44

bioMerieux (France) 45

bioMerieux, Inc. (USA) 45

Bio-Rad Laboratories (USA) 45

Cellabs Pty Ltd (Australia) 45

Celsis International Plc (UK) 45

Coris BioConcept (Belgium) 46

F. Hoffmann-La Roche Ltd. (Switzerland) 46

Gen-Probe Incorporated (USA) 46

Genzyme Diagnostics (USA) 46

Inverness Medical Innovations, Inc. (USA) 47

MedMira, Inc. (Canada) 47

Meridian Biosciences, Inc. (USA) 47

Orasure Technologies, Inc. (USA) 47

Orion Diagnostica Oy (Finland) 47

Quidel Corporation (USA) 47

Siemens Healthcare Diagnostics (USA) 48

Thermo Fisher Scientific, Inc. (USA) 48

Remel, Inc. (USA) 48

Oxoid Limited (UK) 48

8. GLOBAL MARKET ANALYTICS 49

9. THE UNITED STATES 59

Rapid Microbiology Tests - A Competitive Profile 59

Consolidation in the Automated and Rapid Microbiological

Tests Market 59

Bioterrorism Tests - Gaining Prominence 59

Tracking Trends Across Product Segments 60

STD Rapid Tests 60

Market Share Trends of Leading Players: 60

Leading Players in HIV Rapid Testing Market 61

Gastrointestinal Rapid Tests 62

Market Share Trends of Leading Players 62

Respiratory Rapid Tests 63

Competition 64

Streptococcus Infection Rapid Tests 65

Average Prices 66

A Peek into the Testing Practices of the US Food Industry 68

10. EUROPE 71

a. France 78

b. Germany 81

c. The United Kingdom 84

d. Italy 87

e. Spain 89

f. Russia 91

g. Rest of Europe 92

11. REST OF WORLD 94

Latin American Market 94

Asia-Pacific - The Next Epicenter for the AIDS Epidemic 94

Table 1: Percentage Breakdown of Leading Players in World

Market for IVD Automated Microbiology Systems - 2000

Table 2: Global Automated and Rapid Microbiological Tests

Market by Region for the Period 2007-2015 (Sales in US$

Million)

Table 3: Percentage Breakdown of Global Automated and Rapid

Microbiological Tests Market by Region for the Years 2008 &

2012

Table 4: Global Market for Automated and Rapid

Microbiological Tests in Clinical Applications by Region for

the Period 2007-2015 (Sales in US$ Million)

Table 5: Percentage Breakdown of Global Market for Automated

and Rapid Microbiological Tests in Clinical Applications by

Region for the Years 2008 & 2012

Table 6: Global Market for Automated and Rapid Microbiological

Tests in Clinical Applications by Equipment Used for the

Period 2007-2015 (Sales in US$ Million)

Table 7: Percentage Breakdown of Global Market for Automated

and Rapid Microbiological Tests in Clinical Applications by

Equipment Used for the Years 2008 & 2012

Table 8: Global Market for Automated Identification &

Susceptibility Systems in Clinical Applications by Region for

the Period 2007-2015 (Sales in US$ Million)

Table 9: Percentage Breakdown of Global Market for Automated

Identification & Susceptibility Systems in Clinical

Applications by Region for the Years 2008 & 2012

Table 10: Global Market for Automated Blood Culture Systems in

Clinical Applications by Region for the Period 2007-2015

(Sales in US$ Million)

Table 11: Percentage Breakdown of Global Market for Automated

Blood Culture Systems in Clinical Applications by Region for

the Years 2008 & 2012

Table 12: Global Market for Automated Tuberculosis Systems in

Clinical Applications by Region for the Period 2007-2015

(Sales in US$ Million)

Table 13: Percentage Breakdown of Global Market for Automated

Tuberculosis Systems in Clinical Applications by Region for

the Years 2008 & 2012

Table 14: Global Market for Streptococcal Infection Rapid

Tests in Clinical Applications by Region for the Period

2007-2015 (Sales in US$ Million)

Table 15: Percentage Breakdown of Global Market for

Streptococcal Infection Rapid Tests in Clinical Applications

by Region for the Years 2008 & 2012

Table 16: Global Market for GC/Chlamydia Rapid Tests in

Clinical Applications by Region for the Period 2007-2015

(Sales in US$ Million)

Table 17: Percentage Breakdown of Global Market for

GC/Chlamydia Rapid Tests in Clinical Applications by Region

for the Years 2008 & 2012

Table 18: Global Market for Other Automated & Rapid

Microbiological Tests in Clinical Applications by Region for

the Period 2007-2015 (Sales in US$ Million)

Table 19: Percentage Breakdown of Global Market for Other

Automated & Rapid Microbiological Tests in Clinical

Applications by Region for the Years 2008 & 2012

Table 20: Global Market for Automated and Rapid

Microbiological Tests in Non-Clinical Applications by Region

for the Period 2007-2015 (Sales in US$ Million)

Table 21: Percentage Breakdown of Global Market for Automated

and Rapid Microbiological Tests in Non-Clinical Applications

by Region for the Years 2008 & 2012

Table 22: Percentage Breakdown of Leading Players in the US

Market for GC/Chlamydia Rapid Tests - 2005

Table 23: Percentage Breakdown of Leading Players in the US

Market for Chlamydia Rapid Tests - 2005

Table 24: Percentage Breakdown of Leading Players in the US

Market for Syphilis Rapid Tests - 2005

Table 25: Percentage Breakdown of Leading Players in the US

Market for C. Difficile Rapid Tests - 2005

Table 26: Percentage Breakdown of Leading Players in the US

Market for Cryptosporidium Rapid Tests - 2005

Table 27: Percentage Breakdown of Leading Players in the US

Market for Rotavirus Rapid Tests - 2005

Table 28: Percentage Breakdown of Leading Players in the US

Market for Giardia Rapid Tests - 2005

Table 29: Percentage Breakdown of Leading Players in the US

Market for Influenza Rapid Tests - 2005

Table 30: Percentage Breakdown of Leading Players in the US

Market for RSV Rapid Tests - 2005

Table 31: Percentage Breakdown of Leading Players in the US

Marketfor Tuberculosis Rapid Tests - 2005

Table 32: Percentage Breakdown of Leading Players in the US

Market for M. Pneumoniae Rapid Tests - 2005

Table 33: Percentage Breakdown of Leading Players in the US

Market for Mononucleosis Rapid Tests - 2005

Table 34: Percentage Breakdown of Leading Players in the

USMarket for Streptococcus A Rapid Tests - 2005

Table 35: Average Costs for Rapid Tests in the US

Table 36: Automated and Rapid Microbiological Tests Market by

End-Use Segment in the US: 2007-2015 (Sales in US$ Million)

Table 37: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by End-Use Segment in the US for

the Years 2008 & 2012

Table 38: Rapid Microbiological Tests Market by End-Use

Segment in the US: 2007-2015 (Sales in US$ Million)

Table 39: Percentage Breakdown of Rapid Microbiological Tests

Market by End-Use Segment in the US for the Years 2008 & 2012

Table 40: Percentage Breakdown of Leading Players in European

Market for Automated & Rapid Microbiological Tests - 2000

Table 41: Percentage Breakdown of Leading Players in European

Market for Chlamydia Rapid Tests - 2000

Table 42: Percentage Breakdown of Leading Players in European

Market for Streptococcal Infection (Strep A) Rapid Tests -

2000

Table 43: Percentage Breakdown of Leading Players in European

Market for Automated Blood Culture Systems - 2000

Table 44: Automated and Rapid Microbiological Tests Market by

Region in Europe: 2007-2015 (Sales in US$ Million)

Table 45: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by Region in Europe for the Years

2008 & 2012

Table 46: Automated and Rapid Microbiological Tests Market by

End-Use Segment in Europe: 2007-2015 (Sales in US$ Million)

Table 47: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by End-Use Segment in Europe for

the Years 2008 & 2012

Table 48: Percentage Breakdown of Leading Players in French

Market for Automated & Rapid Microbiological Tests - 2000

Table 49: Percentage Breakdown of Leading Players in French

Market for Chlamydia Rapid Tests - 2000

Table 50: Percentage Breakdown of Leading Players in French

Market for Automated Tuberculosis Systems - 2000

Table 51: Percentage Breakdown of Leading Players in French

Market for Automated Blood Culture Systems - 2000

Table 52: Percentage Breakdown of Leading Players in French

Market for Automated Identification and Susceptibility Systems

- 2000

Table 53: Automated and Rapid Microbiological Tests Market by

End- Use Segment in France: 2007-2015 (Sales in US$ Million)

Table 54: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by End-Use Segment in France for

the Years 2008 & 2012

Table 55: Percentage Breakdown of Leading Players in German

Market for Automated & Rapid Microbiological Tests - 2000

Table 56: Percentage Breakdown of Leading Players in German

Market for Streptococcal Infection Rapid Tests - 2000

Table 57: Percentage Breakdown of Leading Players in German

Market for Automated Tuberculosis Systems - 2000

Table 58: Percentage Breakdown of Leading Players in German

Market for Automated Blood Culture Systems - 2000

Table 59: Percentage Breakdown of Leading Players in German

Market for Chlamydia Rapid Tests - 2000

Table 60: Percentage Breakdown of Leading Players in German

Market for Automated Identification and Susceptibility

Systems - 2000

Table 61: Automated and Rapid Microbiological Tests Market by

End-Use Segment in Germany: 2007-2015 (Sales in US$ Million)

Table 62: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by End-Use Segment in Germany for

the Years 2008 & 2012

Table 63: Percentage Breakdown of Leading Players in the UK

Market for Automated & Rapid Microbiological Tests - 2000

Table 64: Percentage Breakdown of Leading Players in the UK

Market for Chlamydia Rapid Tests - 2000

Table 65: Percentage Breakdown of Leading Players in the UK

Market for Automated Tuberculosis Systems - 2000

Table 66: Percentage Breakdown of Leading Players in the UK

Market for Automated Identification and Susceptibility Systems

- 2000

Table 67: Percentage Breakdown of Leading Players in the UK

Market for Streptococcal Infection Rapid Tests - 2000

Table 68: Percentage Breakdown of Leading Players in the UK

Market for Automated Blood Culture Systems - 2000

Table 69: Automated and Rapid Microbiological Tests Market by

End-Use Segment in the UK: 2007-2015 (Sales in US$ Million)

Table 70: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by End-Use Segment in the UK for

the Years 2008 & 2012

Table 71: Percentage Breakdown of Leading Players in Italian

Market for Automated & Rapid Microbiological Tests - 2000

Table 72: Percentage Breakdown of Leading Players in Italian

Market for Streptococcal Infection Rapid Tests - 2000

Table 73: Percentage Breakdown of Leading Players in Italian

Market for Automated Tuberculosis Systems - 2000

Table 74: Percentage Breakdown of Leading Players in Italian

Market for Chlamydia Rapid Tests - 2000

Table 75: Automated and Rapid Microbiological Tests Market by

End- Use Segment in Italy: 2007-2015 (Sales in US$ Million)

Table 76: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by End-Use Segment in Italy for

the Years 2008 & 2012

Table 77: Percentage Breakdown of Leading Players in Spanish

Market for Automated Tuberculosis Systems - 2000

Table 78: Automated and Rapid Microbiological Tests Market by

End-Use Segment in Spain: 2007-2015 (Sales in US$ Million)

Table 79: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by End-Use Segment in Spain for

the Years 2008 & 2012

Table 80: Automated and Rapid Microbiological Tests Market by

End- Use Segment in Russia: 2007-2015 (Sales in US$ Million)

Table 81: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by End-Use Segment in Russia for

the Years 2008 & 2012

Table 82: Percentage Breakdown of Leading Players in

Streptococcal Infection Rapid Tests Market in Rest of Europe -

2000

Table 83: Percentage Breakdown of Leading Players in Automated

Identification and Susceptibility Systems Market in Rest of

Europe - 2000

Table 84: Automated and Rapid Microbiological Tests Market by

End-Use Segment in Rest of Europe: 2007-2015 (Sales in US$

Million)

Table 85: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by End-Use Segment in Rest of

Europe for the Years 2008 & 2012

Table 86: Automated and Rapid Microbiological Tests Market by

End-Use Segment in Rest of World: 2007-2015 (Sales in US$

Million)

Table 87: Percentage Breakdown of Automated and Rapid

Microbiological Tests Market by End-Use Segment in Rest of

World for the Years 2008 & 2012

COMPANIES PROFILED

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